The National CT Colonography Trial
ACRIN6664
4 other identifiers
interventional
2,600
1 country
14
Brief Summary
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Feb 2005
Longer than P75 for not_applicable colorectal-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedStudy Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2010
CompletedResults Posted
Study results publicly available
November 16, 2020
CompletedDecember 22, 2020
November 1, 2020
2.6 years
June 10, 2004
February 5, 2018
November 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=10mm (as measured at pathology) RS-: No Advanced adenomas \>=10mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=9mm (as measured at pathology) RS-: No Advanced adenomas \>=9mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=8mm (as measured at pathology) RS-: No Advanced adenomas \>=8mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=7mm (as measured at pathology) RS-: No Advanced adenomas \>=7mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=6mm (as measured at pathology) RS-: No Advanced adenomas \>=16mm found by colonoscopy (as measured at pathology)
within 30 days
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=5mm (as measured at pathology) RS-: No Advanced adenomas \>=5mm found by colonoscopy (as measured at pathology)
within 30 days
Secondary Outcomes (7)
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
within 30 days
- +2 more secondary outcomes
Study Arms (1)
CT Colonography
EXPERIMENTALCT colonography conducted during the same assessment as colonoscopy.
Interventions
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Eligibility Criteria
You may qualify if:
- Male or female outpatients
- Aged 50 years or older
- Scheduled for screening colonoscopy
- Participant's signed informed consent
You may not qualify if:
- Symptoms of disease of the lower gastrointestinal tract, including
- Melanotic stools or/and hematochezia on more than one occasion in the previous six months
- Lower abdominal pain that would normally require a medical evaluation
- Inflammatory bowel disease and/or familial polyposis syndrome
- Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
- Pregnancy
- Previous colonoscopy within the past five years
- Anemia (hemoglobin less than 10 gm/dl)
- Positive fecal occult blood test (FOBT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
Invision/Radiology Imaging Associates - Englewood
Englewood, Colorado, 80112, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, 62781, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, 63110, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Related Publications (6)
Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3.
PMID: 21813740BACKGROUNDJohnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23.
PMID: 22361006RESULTHara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1.
PMID: 21364081RESULTHara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334.
PMID: 21512073RESULTSiewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.
RESULTJohnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.
PMID: 18799557RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Donna Harfeil, Director of Protocol Management
- Organization
- ACRIN
Study Officials
- STUDY CHAIR
C. Daniel Johnson, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
February 1, 2005
Primary Completion
September 11, 2007
Study Completion
May 13, 2010
Last Updated
December 22, 2020
Results First Posted
November 16, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
Researchers may request data from the ACRIN data access committee by reviewing the information at: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx